Oct 27 (Reuters) – The US FDA on Tuesday warned Amgen that a promotional video for its colorectal cancer drug was misleading because it highlighted the benefits while failing to adequately disclose serious safety risks and patient limitations.
Here are some details:
• In a warning letter dated August 12, the FDA said the video promoted the drug Vectibix as an option for adults with a type of advanced colorectal cancer and noted that infusions can take 60 minutes or less and do not require premedication
• The regulator said that the video contained no information on risk, despite Vectibix carrying a boxed warning for severe skin reactions
• The drug can also cause potentially fatal infusion reactions, lung disease, kidney failure and other serious side effects, the FDA said
• The regulator said the video failed to disclose which type of patients can use Vectibix, including limits tied to tumor testing
• “By failing to adequately communicate the full indication for Vectibix and limitations of use associated with Vectibix, the video creates a misleading impression about the drug’s FDA-approved indication and use,” the FDA said
• The regulator told Amgen to stop using misleading promotional material, submit a written response within 15 working days and propose corrective communications for the video’s audience
• It said failure to address the issues could lead to legal action, including product seizure or an injunction
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shailesh Kuber)
